Chemotherapy and Reduced Intensity Conditioning for Refractory Acute Myeloid Leukemia
Official title: A Phase II Single Arm Study of Cladribine, Cytarabine, Etoposide and Venetoclax Sequential With Reduced Dose Conditioning of Fludarabine, Busulfan and Melphalan or Total Marrow Radiation for Refractory Acute Myeloid Leukemia
Run by Shanghai Jiao Tong University School of Medicine · NCT05870995 · Data updated 2026-11-12
This study is testing a new treatment plan that combines a special chemotherapy with a gentler conditioning method to see if it helps people with hard-to-treat acute myeloid leukemia feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, fludarabine |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | February 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT05870995 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with refractory AML who have not achieved remission after multiple induction therapies and have specific donor matches for transplantation.
✕Probably not a fit
Patients with significant liver or renal dysfunction, or poor cardiac function, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates a new treatment protocol for patients with refractory acute myeloid leukemia (AML) that combines a modified chemotherapy regimen of cladribine, cytarabine, and etoposide (CLAGE) with a reduced intensity conditioning regimen. The aim is to reduce toxicity and relapse rates associated with traditional treatments while improving disease-free survival. The study will assess the efficacy and feasibility of this approach in a multi-center phase II setting, incorporating the addition of Venetoclax to the treatment regimen. Patients will be monitored for their response to the treatment and any adverse effects.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced toxicity for patients with refractory AML.
How similar studies have gone: Previous studies have shown promise with similar chemotherapy and conditioning approaches, but this specific combination is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with refractory AML: no remission after 2 induction therapy, relapsed AML within 6 months of 1st CR, relapse AML fail to having CR after reinduction therapy, multiple relapse and refractory relapse AML * patients with \>5% bone marrow blast by morphology or by LAIP flowcytometry at enrollment * patients with HLA-matched sibling donor, 9-10/10 matched unrelated donor or haplo-identical family donor * patients without active infection * informed consent provided Exclusion Criteria: * patients with abnormal liver function (enzyme \>2N or bilirubin \>2N) * patients with abnormal renal function (Scr \>1.5N) * patients with poor cardiac function （EF\<45%）
Where it's running
-
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China Recruiting -
Department of Hematology, Shanghai No 6 Hospital
Shanghai, China Recruiting -
Shanghai ZhaXin Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Jiong HU
- Email: hj10709@rjh.com.cn
- Phone: 86-21-64370045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.